investigation news from FierceBiotech

Life in the biotech fast lane is good for investors, not so great for patients--or so says the Cleveland Plain Dealer after a seven-month investigation of the FDA's record on fast-track drugs. Read more...

Novo Nordisk's long-lasting insulin drug Levemir turned in mixed results in a Phase III trial. Bad news first: Patients taking the drug were less likely to achieve blood sugar control than those Read more...

With lawmakers poised to consider new legislation on generic drugs, the FTC has concluded that the drug industry is increasingly paying generic drugmakers to stop them from rolling out cheap knockoffs. Half of the 28 patent litigation settlements struck in the year leading up to Sept. 30 included such a pact. The Senate Judiciary Committee has begun an investigation into the payments, which two appeals court decisions concluded were legal in 2005. Report

The FDA is continuing to investigate a case of sometimes fatal rash that developed during a clinical trial of Sparlon, an experimental therapy for sleep disorder, according to an announcement from Cephalon. And that investigation could cause a delay in the agency's decision on Nuvigil, a next-generation therapy that follows Provigil. All three therapies rely on modafinil as the active ingredient. Cephalon says that the time needed to finish the Sparlon review may require an extension of …

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Israel's Taro Pharmaceutical's CFO, Kevin Connelly, has resigned following an investigation into the company's restatement of earnings for 2003 and 2004. A report from the law firm Jenner & Block asserted that the company's financial team had made "misrepresentations" to the SEC and Ernst & Young. Connelly and another member of Taro's financial team, who was unnamed, resigned from the company after disagreeing strongly with the conclusions of the report. Taro also announced that …

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If you haven't heard of Morgellons disease, you may soon. Fueled by a popular website outlining its symptoms, thousands of patients are reporting that they have the as-yet undocumented illness. Patients claiming to have Morgellons flooded the Centers for Disease Control and Prevention, which has launched an investigation of the phenomenon.

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Shares of ConjuChem Biotechnologies took a nasty hit Friday morning, plunging 34 percent after the company announced it had suspended a Phase II trial of an HIV therapy as it investigates the death of a patient in the study. ConjuChem announced it would halt dosing in the trial of an experimental therapy for HIV lipodystrophy. "The cause of death and the relationship of the study drug to the event, which occurred at a clinical site in Argentina, is currently under investigation," the …

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Cypress Bioscience has pulled the plug on its development program for a combination therapy including mirtazapine for sleep apnea. Phase IIa results don't warrant further investigation, researchers say. Cypress and Organon--a division of Akzo Nobel--each conducted independent studies and are now looking at alternatives to continue their collaboration.

- here's the report on Cypress from StreetInsider.com

Following yesterday's troubling review of Sanofi-Aventis' antibiotic Ketek in The Wall Street Journal, a number of Congressmen have launched calls for an investigation into its approval. Some, like Representative Henry A. Waxman, say the FDA's action highlights the need for reform at the agency. The Journal reported that a number of patients taking the drug have died and raised a number of questions about Aventis' last drug trial.

"Recently the GAO found …

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An investigation into a small drug trial that went disastrously wrong in the UK has found that the drug maker and the clinical trial organization that mounted the study had not made any mistakes in formulating the drug or administering it. Instead, the regulators said, TGN1412 had provoked an unexpected biologic reaction in humans, sending six men to the hospital.

- here's the article from the Guardian